OLYMPUS SIGMOIDOFIBERSCOPE

Description of Event or Problem

OLYMPUS WAS INFORMED THAT THE USER FACILITY WAS NOT REPROCESSING THE ENDOSCOPE IN ACCORDANCE WITH THE DIRECTIONS FOR USE. THE USERS WERE REPORTEDLY SPRAYING ONLY THE ENDOSCOPE WITH A DISINFECTANT FOLLOWING THE PROCEDURE, AND DRYING THE ENDOSCOPE OFF PRIOR TO USING AGAIN ON ANOTHER PT. THERE WERE NO REPORTS OF ANY INFECTIONS OR OTHER ADVERSE IMPACTS TO PTS.

Additional Manufacturer Narrative

OLYMPUS CONTACTED THE USER FACILITY TO OBTAIN ADD'L INFO REGARDING THE REPORT AND WAS INFORMED THAT THERE WAS NO PT INFECTION OR CROSS CONTAMINATION ASSOCIATED WITH THE REPORT. THE USER FACILITY STAFF MENTIONED THAT THE SUBJECT DEVICE HAS BEEN ISOLATED SINCE THE OLYMPUS' ENDOSCOPY SUPPORT SPECIALIST'S (ESS) VISIT. THE SUBJECT DEVICE HAS NOT YET BEEN RETURNED TO OLYMPUS FOR EVAL. THE ESS PROVIDED A REPROCESSING IN-SERVICE TO THE USER FACILITY'S STAFF ON HOW TO PROPERLY REPROCESS ENDOSCOPES. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN EXCESS OF CAUTION.